MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number	DCB00
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, a4 and a5: unknown, as information was requested but not provided.Section d6a - implant date: not applicable, as there is no indication that the lens was implanted.Section d6b - explant date: not applicable, as there is no indication that the lens was implanted.Section e1 - telephone number: (b)(6).Section h3: the intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.A review of records related to the device including labeling and complaint trending will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded monofocal intraocular lens (iol) became stuck inside the injector and was subsequently ejected in a damaged state.The tip of the cartridge was in contact with the patient's eye.A replacement iol was implanted.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes section d9 - date returned to manufacturer: the device was not returned to the manufacturer, a photo was evaluated.Section h3 - device evaluated by manufacturer? yes device evaluation: the photo provided by the customer was evaluated.The photos show the suspect handpiece, original folding carton, and lens.The plunger rod was observed to be fully advanced and the lens was observed to be coated in viscoelastic residue.A scratch was observed on the lens.Due to no product received, no further evaluation could be performed.The complaint issue "lens damaged" was not identified during photo evaluation.The observed "cosmetic issues" is similar to the reported complaint issue.However, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The complaint issue "stuck in cartridge" was not identified during photo evaluation.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes section d9 - date returned to manufacturer: august 19, 2025¿ section h3 - device evaluated by manufacturer? yes device evaluation: visual inspection under magnification revealed that the handpiece was received with the lens module and cartridge disassembled from the handpiece; the plunger rod was fully retracted.Viscoelastic residue was observed throughout the cartridge.The cartridge was observed to be damaged and the cartridge tip was cut off.Viscoelastic residue was observed below the lens module, in the lens module, and on the lens module lid indicating that an excessive amount of ophthalmic viscosurgical device (ovd) may have been used.No resistance was identified during plunger rod advancement; however, the plunger rod was observed to be bent.The lens was received coated in viscoelastic residue.The lens was cleaned and inspected revealing scratches.The complaint issue "lens damaged" was not identified during product evaluation.The observed "cosmetic issues" is similar to the reported complaint issue.However, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The complaint issue "stuck in cartridge" was not identified.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction were found.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 22207971
• Report Number: 3012236936-2025-000154
• Device Sequence Number: 20554732
• Product Code: HQL
• UDI-Device Identifier: 05050474635838
• UDI-Public: (01)05050474635838(17)270603
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 07/28/2025; 09/24/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/19/2025; 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown